{"schema_version":"secwatch.filing_event.v1","accession":"0001437749-24-005132","form_type":"8-K","ticker":"CLNN","cik":"0001822791","company_name":"Clene Inc.","filed_at":"2024-02-22T23:59:59+00:00","discovered_at":"2026-05-14T18:03:25.746232+00:00","generated_at":"2026-06-05T20:46:31.265665+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"Clene reports significant survival benefit with CNM-Au8 in ALS compassionate use programs","bullets":["68% decreased risk of all-cause mortality vs PRO-ACT matched controls (HR=0.320, p=0.0001).","57% decreased risk of all-cause mortality vs ALS Natural History Consortium matched controls (HR=0.433, p=0.0001).","Data from 256 EAP participants (220 matched); no serious adverse events attributed to CNM-Au8.","Results support advancing CNM-Au8 to Phase 3 testing in ALS; $45.1M NIH grant for third EAP.","CNM-Au8 30 mg well-tolerated with up to 4 years of dosing; EAP enrollment in H1 2024 planned."],"urls":{"canonical":"https://secwatch.observer/filing/0001437749-24-005132","json":"https://secwatch.observer/filing/0001437749-24-005132.json","markdown":"https://secwatch.observer/filing/0001437749-24-005132.md","text":"https://secwatch.observer/filing/0001437749-24-005132.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1822791/000143774924005132/0001437749-24-005132-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1822791/000143774924005132/clnn20240221_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-05T20:46:31.265665+00:00"},"review":{"review_status":"machine_generated","human_reviewed":false,"corrected":false,"correction_note":null,"correction_timestamp":null,"superseded_by":null,"related_filings":[]},"source_grounded_claims":[],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}